Endocrowns in Anterior Teeth: Effect of Cementation Protocols and Restorative Materials on the Clinical Performance of the Restorations

July 26, 2023 updated by: Nehal Samra, Kafrelsheikh University
Rehabilitation of anterior endodontically treated teeth with significant coronal damage has been problematic. Adopting endocrown design to treat teeth with this condition is still under investigation. To address this issue, the USPHS criteria were adopted to assess the anterior endocrown restorations manufactured using various ceramic materials and cemented with different protocols.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

40 participants with anterior endodontically treated maxillary central incisors were enrolled to restore their teeth with esthetic restorations Patients were divided into two groups, zirconia and e-max groups. Each group was, further subdivided into two groups following the cementation protocol. Patients were evaluated immediately (baseline) and at. The clinical marginal accuracy measurements were carried out for all groups at baseline, 3, 6, 9, 12, and 18 months and evaluated by 3 investigators using Modified (USPHS). The patients' satisfaction and potential postoperative discomfort were also assessed and recorded during the same periods. All qualitative data were displayed as frequency (N) and Percentages (%). The chi-square test was utilized for qualitative data comparisons.

Results:

As to marginal integrity and patient satisfaction, no significant difference were revealed regarding all scores at different intervals as P>0.05.

Conclusions:

According to the findings of this study, ceramic endocrowns offer a promising restorative solution for the rehabilitation of anterior endodontically treated teeth. Additionally, regardless of the presence of the MDP monomer in its composition, using adhesive resin cement achieved highly successful results when used with MDP-based ceramic primers.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 33516
        • Faculty of Dentistry,Mansoura university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • • Freshly extracted teeth.

    • Completely formed apices
    • Minimum root length of 14mm (± 0.5) measured from the cement-enamel junction to the root apex.
    • Straight roots.
    • Teeth with single root canal.
    • Sound teeth with no cracks or fractured parts in its crown or root.
    • Absence of any carious lesions.
    • No signs of internal or external root resorption.
    • Similar bucco-lingual (BL) and mesio-distal (MD) dimensions as determined with a digital caliper.

Exclusion Criteria:

  • • Previously endodontically treated teeth.

    • Markedly curved roots.
    • Root contains more than one canal.
    • Presence of canal calcifications or pulp stones.
    • Internal or external root resorption.
    • Presence of cracks, fractures or caries.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group ZA
Participants received Zirconia anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ MDP-containing resin cement.
Other: resin cement containing phosphate ester monomer 10-methacryloyloxydecyl dihydrogen phosphate
Adhesive resin cement containing an MDP agent that is added to bonding agents to enhance bonding to ceramics like Ziconia and E-max
Other Names:
  • Panavia SA
Experimental: Ggroup ZB
Participants received Zirconia anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ Non-MDP-containing resin cement.
Other: Non MDP containg resin cement
Adhesive resin cement not containing an MDP agent
Other Names:
  • Duo-link Universal
Experimental: Group EA
Participants received E-max anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ MDP-containing resin cement.
Other: resin cement containing phosphate ester monomer 10-methacryloyloxydecyl dihydrogen phosphate
Adhesive resin cement containing an MDP agent that is added to bonding agents to enhance bonding to ceramics like Ziconia and E-max
Other Names:
  • Panavia SA
Experimental: Group EB
Participants received E-max anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ Non-MDP-containing resin cement.
Other: Non MDP containg resin cement
Adhesive resin cement not containing an MDP agent
Other Names:
  • Duo-link Universal

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Marginal Integrity
Time Frame: 3-6-9-12 Months
Using a dental mirror and a dental explorer, endocrowns were checked from every aspect, buccal, mesial, distal and lingual to detect any marginal discontinuity, fractures, or gaps. Endocrown evaluation was carried out against The Modified USPHS criteria
3-6-9-12 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Satisfaction
Time Frame: 3-6-9-12 Months
Each patient was asked about his opinion regarding the restoration. Patients' answers and/or complaints were assessed and recorded against the USPHS criteria
3-6-9-12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kafrelsheikh University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Lamia Dawood, Professor, Professor of Fixed Prosthodontics, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 2, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M01160321

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings